Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty.
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ABSTRACT:
SUBMITTER: Sun P
PROVIDER: S-EPMC6464532 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair.The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ?18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited (58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias). This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one.Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients.ClinicalTrials.gov: NCT01641718.
| S-EPMC3994239 | biostudies-literature
Project description: Not available
| S-EPMC6562263 | biostudies-literature
Project description:BackgroundMesh-based repair is the standard of surgical care for symptomatic inguinal hernias. Many systematic reviews and meta-analyses (SRMAs) addressed various aspects of these procedures. This umbrella review aimed to report the evidence from all previous SRMAs for open and laparoscopic inguinal hernia repair.MethodsSRMAs were identified from MEDLINE, Scopus, Cochrane, Embase, DARE, PROSPERO, CINAHL, JBISRIS, EPPI-Centre, Wiley Online Library and ScienceDirect database according to PRISMA guidelines. Data including mesh-fixation techniques and surgical approach were extracted from selected SRMAs. The corrected covered area was calculated to address study overlap across reviews, and an excess significance test was used to assess potential bias. The outcomes of interest were hernia recurrence, chronic groin pain, operating time, postoperative pain, duration of hospital stay, return to daily life activities, and postoperative complication.ResultsThirty SRMAs were included between 2010 and 2019: 16 focused on open repair, and 14 focused on laparoscopic repair, with a high degree of overlap (open repairs, 41 per cent; laparoscopic repairs, 30-57 per cent). Sufficient evidence was available on hernia recurrence, chronic groin pain, and operative time. Effects of glue on hernia recurrence were inconclusive in open and laparoscopy approaches, P = 0.816 and 0.946 respectively. Glue was significantly associated with lower persistent groin pain, in open repair (versus suture) and in laparoscopic repair (versus tack). SRMAs suggested that self-gripping mesh was associated with shorter operating time in open surgery, although with only a few minutes of improvement (0.36-7.85 min, P < 0.001).ConclusionIn this umbrella review, chronic groin pain and operating time were the only outcomes for which there was sufficient evidence supporting the effectiveness respectively of glue and self-gripping mesh.
| S-EPMC9271883 | biostudies-literature
Project description:BACKGROUND-PURPOSE:Totally extraperitoneal (TEP) endoscopic hernioplasty and Lichtenstein hernioplasty are the most commonly used approaches for inguinal hernia repair. However, current evidence on which is the preferred approach is inconclusive. This updated meta-analysis was conducted to track the accumulation of evidence over time. METHODS:Studies were identified by a systematic literature search of the EMBASE, PubMed, Cochrane Library, and Google Scholar databases. Fixed- and random-effects models were used to cumulatively assess the accumulation of evidence over time. RESULTS:The TEP cohort showed significantly higher rates of recurrences and vascular injuries compared to the Lichtenstein cohort; [Peto Odds ratio (OR)?=?1.58 (1.22, 2.04), p?=?0.005], [Peto OR?=?2.49 (1.05, 5.88), p?=?0.04], respectively. In contrast, haematoma formation rate, time to return to usual activities, and local paraesthesia were significantly lower in the TEP cohort compared to the Lichtenstein cohort; [Peto OR?=?0.26 (0.16, 0.41), p???0.001], [mean difference?=?- 6.32 (- 8.17, - 4.48), p???0.001], [Peto OR?=?0.26 (0.17, 0.40), p???0.001], respectively. CONCLUSIONS:This study, which is based on randomised-controlled trials (RCTs) of high quality, showed significantly higher rates of recurrences and vascular injuries in the TEP cohort than in the Lichtenstein cohort. In contrast, rate of postoperative haematoma formation, local paraesthesia, and time to return to usual activities were significantly lower in the TEP cohort than in the Lichtenstein cohort. Future multicentre RCTs with strict adherence to the standards recommended in the Consolidated Standards of Reporting Trials guidelines will shed further light on the topic.
| S-EPMC6938473 | biostudies-literature
Project description:UNLABELLED:The relationship between mesh weight and host tissue reaction has, so far, not been fully investigated. Lightweight meshes (LWM) are thought to give less inflammatory response compared with heavyweight meshes (HWM). The present study is a randomized, controlled, double-blind clinical trial performed in 61 patients who underwent an elective inguinal hernioplasty. The primary outcome of the study was to investigate the relationship between total amount of prosthetic material (polypropylene), immunological reaction, and oxidative stress. The study was double-blinded. Sixty-one patients were recruited for the study and randomly assigned to 2 groups (groups A and B). Levels of inflammation markers (interleukin-6 [IL-6] and tumor necrosis factor-? [TNF-?]) and oxidative stress markers (reduced glutathione [GSH] and lipid hydroperoxides [LOOH]) were determined preoperatively and after undergoing inguinal hernioplasty (after 6, 72, and 288 hours), respectively, with LWM and HWM. There was no significant difference in IL-6 levels between HWM and LWM (P = 0.3, 0.7, 0.8 after 6, 72, and 288 hours, respectively). A statistically significant difference was found after 72 hours for TNF-? (P = 0.01), for GSH after 6 hours (P?<?0.01), and after 6 and 72 hours for LOOH (P = 0.05, 0.01, respectively). Oxidative stress occurred at earlier time points and was pore accentuated HWM versus LWM and prodromal to TNF-? increase.Also, in randomized clinical trial, the use of LWM gives advantages in terms of less inflammatory response when compared with HWM. Moreover, there is a significant higher oxidative stress after implantation of HWM. The intensity of oxidative stress seems to be strongly related to the amount of implanted polypropylene. ( TRIAL REGISTRATION NUMBER:NCT01090284).
| S-EPMC4998441 | biostudies-literature
Project description:The inguinal hernia accounts for 50 percent in old age males. A Lichtenstein type of operation has now become the method of choice in most developed countries but in the developing world traditional simple suture repair is still in common practice in resource limited hospitals due to the scarcity and expensive nature of the commercial prosthetic mesh. Our objective was to compare the rates of complications in Lichtenstein repair to tension free Darn repair.Ninety two male patients from 20-60 years of age reported for direct or indirect inguinal hernia with open Mesh/Lichtenstein or darn repair in emergency or electively from January 2014 to December 2015 were enrolled in this prospective randomized control trial (RCT). The primary end point was to compare the surgical site infection, length of hospital stay and hernia recurrence with different techniques.The hospital stay was higher in patients who had Lichtenstein repair, Superficial surgical site infections in cohort A (6.5%) and cohort B (4.36%)were noted. Complications of recurrence in Group-A were (1.5%) as compared to Group-B which had a recurrence of 6.52%.Lichtenstein is more promising in comparison to Darn repair in terms of recurrence in inguinal hernia.
| S-EPMC5510130 | biostudies-other
Project description:PurposeThis study reports economic evaluation of mesh fixation in open and laparoscopic hernia repair from a prospective real-world cohort study, using cost-effectiveness analysis (CEA) and cost-utility analysis (CUA).MethodsA prospective real-world cohort study was conducted in two university-based hospitals in Thailand from November 2018 to 2019. Patient data on hernia features, operative approaches, clinical outcomes, associated cost data, and quality of life were collected. Models were used to determine each group's treatment effect, potential outcome means, and average treatment effects. An incremental cost-effectiveness ratio was used to evaluate the incremental risk of hernia recurrences.ResultsThe 261 patients in this study were divided into six groups: laparoscopic with tack (LT, n = 47), glue (LG, n = 26), and self-gripping mesh (LSG, n = 30), and open with suture (OS, n = 117), glue (OG, n = 18), and self-gripping mesh (OSG, n = 23). Hernia recurrence was most common in LSG. The mean utility score was highest in OG and OSG (both 0.99). Treatment costs were generally higher for laparoscopic than open procedures. The cost-effectiveness plane for utility and hernia recurrence identified LSG as least cost effective. Cost-effectiveness acceptability curves identified OG as having the highest probability of being cost effective at willingness to pay levels between $0 and $3,300, followed by OSG.ConclusionGiven the similarity of hernia recurrence among all major procedures, the cost of surgery may impact the decision. According to our findings, open hernia repair with adhesive or self-gripping mesh appears most cost-effective.
| S-EPMC9450344 | biostudies-literature
Project description:BackgroundThe Shouldice method and other tissue-based techniques are still acknowledged to be acceptable for primary inguinal hernia repair according to the European Hernia Society guidelines. Desarda's technique, presented in 2001, is an original hernia repair method using an undetached strip of external oblique aponeurosis. This randomized trial compared outcomes after hernia repair with Desarda (D) and mesh-based Lichtenstein (L) techniques.MethodsA total of 208 male patients were randomly assigned to the D or L group (105 vs. 103, respectively). The primary outcomes measured were recurrence and chronic pain. Additionally, early and late complications, foreign body sensation, and return to everyday activity were examined in hospital and at 7, 30 days, and 6, 12, 24, and 36 months after surgery.ResultsDuring the follow-up, two recurrences were observed in each group (p = 1.000). Chronic pain was experienced by 4.8 and 2.9% of patients from groups D and L, respectively (p = 0.464). Foreign body sensation and return to activity were not different between the groups. There was significantly less seroma production in the D group (p = 0.004).ConclusionsThe results of primary inguinal hernia repair with the Desarda and Lichtenstein techniques are comparable at the 3-year follow-up. The technique may potentially increase the number of tissue-based methods available for treating groin hernias.
| S-EPMC3321139 | biostudies-literature
Project description:BACKGROUND:Technical factors leading to hernia recurrence after transabdominal preperitoneal repair include insufficient dissection, inadequate prosthetic overlap and prosthetic size, improper fixation and folding, or crinkling of the prosthesis. However, determining intraoperatively if a case will develop recurrent hernias due to these factors remains unclear. METHODS:Five surgeons blind-reviewed operation videos of primary laparoscopic hernioplasty in 13 lesions that went on to develop recurrent hernias (i.e., future recurrence), as well as 28 control lesions, to assess twelve items of surgical techniques. Since we changed a surgical policy of covering myopectineal orifice (MPO) in April 2003, we analyzed the data for the earlier and later periods. The data was analyzed with hierarchical clustering to obtain a gross grouping. The differences of the ratings between the future recurrent and control lesions were then analyzed and the association of the techniques with the hernia recurrence rate, the size of the prosthesis, and the hernia type across hernia recurrence were explored. RESULTS:The lesions were grouped based on the time series, and its boundary was approximated when we changed our surgical policy. This policy change caused ratings to progress from 34% satisfactory, to 79% satisfactory. The recurrence rate decreased to 0.7% (5/678), compared with 6.2% (10/161) before the policy was implemented (p?<?0.001). With univariate analysis, the ratings of posterior prosthesis overlap to the MPO in the recurrent lesions were significantly lower than controls in the later period (p?=?0.019). Although various types of recurrences were noted in the earlier period, only primary indirect and recurrent indirect hernias were observed in the later period (p?=?0.006). CONCLUSIONS:Fully covering the MPO with mesh is essential for preventing direct recurrence hernias. Additional hernia recurrence prevention can be obtained by giving appropriate attention to prosthesis overlap posterior to the MPO in a large indirect hernia.
| S-EPMC7011534 | biostudies-literature
Project description:BackgroundConscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard.ObjectiveTo determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty.MethodsThis trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status.ResultsTo date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017.ConclusionsThis randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines.Trial registrationClinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).
| S-EPMC5320391 | biostudies-literature